An operation of making a culture medium from a specimen in order to determine the presence or absence of bacteria or fungi in a specimen comprising a vial filled with powder or fluid by using a membrane filter is known.
The present invention concerns a sterile test apparatus for testing this vial, and more particularly an apparatus that makes maximum use of the benefits of an operating apparatus for sterile testing.
However, the present invention is not limited to a sterile test apparatus; with a partial alteration and/or addition, it can also be similarly used as an automatic testing apparatus for all microorganism testing as well as an automatic testing apparatus for insoluble particulate testing done under the same conditions and performing the same operations as those for sterile testing.
Therefore, the present invention concerns an automatic testing apparatus that can be utilized for all the above-mentioned tests.
The following explanation uses an example of the present invention utilized as an automatic sterile testing apparatus.
Conventionally, the making of a sample in order to determine the presence or absence of germs by using a membrane filter method, as for example shown in the drawings (FIG. 1) describing the conventional art in Laid-Open Patent Application No. 63-230077, has involved a vacuum suction filtration method employing syringes, flasks, funnels and the like, and has been performed entirely as a manual operation.
However, this vacuum suction filtration method presupposes operation by human hands inside a clean room, and it is difficult to completely prevent contamination of the clean room by technicians. That is, with the vacuum suction filtration method there is a possibility of obtaining false positive readings because of the possibility that ambient air gets drawn into the specimen, thus calling into question the accuracy of the test.
In order to solve this problem a sterile test unit employing a pressurized filtration method consisting of a suction needle and two culture tubes to each of which is connected two tubes has been developed, greatly reducing the introduction of germs from the operating environment into the specimen during testing.
However, even with use of this sterile test unit it is difficult to prevent contamination of the environment by people when carrying out a series of manual operations inside the clean room and the introduction of germs cannot be completely eliminated. In addition, existing problems of procedural mistakes during operation, poor test efficiency and high cost remain unaddressed.
As a means of resolving these problems the vial automatic sterile test unit of Laid-Open Patent Application 63-230077 previously mentioned has been developed. However, said apparatus, too, has the following problems and is not the fundamental problem resolution sought for sterile testing operations.
1) When the necessary equipment is added to said apparatus (in the preparatory stage), humans must enter the clean room in order to work. The interior of the clean room is contaminated when humans enter the clean room, sterile testing is done in a contaminated environment and the possibility of false positives remains a concern.
2) When a plurality of samples of different funnels are positioned at said apparatus, the structure of the apparatus is such that the injection needle used to inject the solutions does not change even though the sample changes, so there is a chance that the samples may be contaminated beginning with the second sample.
3) The specimen transport tray must be replaced every time there is a change in either the shape of the specimen container, the volume of the specimen per single sample, the shape of containers other than those of the specimen, the volume or the testing order, making for extraordinarily frequent and complex operation and an extraordinarily large number of trays, necessitating storage space for the trays and creating a large additional burden of keeping track of the trays as well.
4) The stock device for all the container cases is a surface-arrangement type and moreover a stock device is needed for both before and after testing, so the larger the number of samples per device the greater the area required by the device, which means that the number of samples that can be processed per set inside an existing clean room cannot be large.
5) The order of operation is fixed and each and every one of these processes must be started simultaneously, so the interval required by the process that takes the longest is the required interval, making the entire time required for the test very lengthy.
6) The order of operation is fixed, so when the same operation is repeated additional devices for such operation must be added to the apparatus, increasing the area required and adding to the cost.
7) The unit only uses vials, and cannot be adapted either to other types of specimen containers (such as ampules, transfusion solution bags, eyedroppers, etc.) or to other purposes (such as the direct method of making samples for sterile testing), making it necessary consider other types of equipment adapted to each type of container or vial.
It is the general object of the present invention to provide an improved and useful automatic testing apparatus that solves problems like those mentioned above.
A more specific object of the present invention is to provide an automatic testing apparatus that performs automatically, without any human intervention whatsoever, even when there are changes in the operations required for the test depending on the shape and size of the specimen to be tested, the method of testing or the order of operations, and which reduces the frequency and complexity of operations and performs mistake-free operation with a high degree of accuracy.
The object of the present invention is achieved by an automatic testing apparatus comprising a work base mounting the test specimen as well as equipment required for the testing of the specimen; a robot device for moving according to a previously determined procedure said test specimen and equipment mounted on said work base set at a predetermined testing position for performing predetermined tests on a test specimen mounted on the work base; and a work base providing mechanism for providing the work base to the testing position, such that the specimen to be tested can be changed on a work base-unit basis.
According to the above-mentioned automatic testing apparatus, by simply setting the test specimen as well as the equipment required for the test specimen on the work base, the test specimen and equipment mounted on said work base are moved by the robot device according to a predetermined order and the required tests executed. As a result, by pre-programming the robot device to perform test procedures on an individual work-base basis for each test specimen, a variety of tests are performed automatically without human intervention, thus reducing the frequency and complexity of operations and making it possible to perform mistake-free operations of high reliability.
In addition, another object of the present invention is to provide an automatic testing apparatus that is capable of performing automatically the many above-mentioned operations with respect to specimens without fear of contamination by germs from human hands even without the use of a clean room, that is more simplified in structure and from which highly accurate test results can be expected.
The object of the present invention is achieved by an automatic testing apparatus having a sealed first partition chamber enclosing a range of handling operation of a robot device, said first partition chamber comprising a sealable port portion for work base entry and exit, a filter unit positioned on a top portion of said first partition chamber, and exhaust ports positioned on the bottom portion and side surface portions, and structured so as to permit the operation of said robot device inside said first partition chamber comprising a clean booth function.
According to an automatic testing apparatus of this type, the testing of a test specimen on the work base can be carried out automatically by the robot device without fear of contamination by germs from human hands even without the use of a clean room, the automatic testing apparatus itself being one that is more simplified in structure and from which highly accurate test results can be expected.
In addition, the present invention provides on a front step of the first partition chamber a work base stock device so that work bases can be continuously supplied to the first partition chamber that demarcates the range of operation of the robot device, with the work base providing mechanism structured so as to be able to provide from said stock device each work base to said test position inside said partition chamber.
Moreover, the present invention provides on every above-mentioned automatic testing apparatus a sealed second partition chamber enclosing said stock device so that germs can be prevented from entering during the process of providing the test specimen to the robot device, with said second partition chamber comprising a sealable port portion for work base entry and exit and exhaust ports positioned on the bottom portion and side surface portions, so as to permit operation of said stock device inside said second partition chamber comprising a clean booth function.
The present invention can be structured so that the work bases can returnably move between the first partition chamber and the second partition chamber, so that the exchange of work bases is simple.
In addition, the present invention can be made to be equipped with a disinfecting means for spray-misting a disinfectant fluid into at least one of the first partition chamber and second partition chamber, so that the adhesion of germs to the test specimen may be even further prevented.
It is preferable that this disinfectant fluid be strong-acid ionized water.
Similarly, the present invention can be equipped with a UV lamp emitting germ-killing rays and an ozone-generating lamp inside the first partition chamber, so that the adhesion of germs to the test specimen may be even further prevented.